Myrbetriq is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Mirabegron.
| Product ID | 70518-3158_c72d36fe-33e6-2944-e053-2a95a90a9275 |
| NDC | 70518-3158 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Myrbetriq |
| Generic Name | Mirabegron |
| Dosage Form | Tablet, Film Coated, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2021-07-15 |
| Marketing Category | NDA / |
| Application Number | NDA202611 |
| Labeler Name | REMEDYREPACK INC. |
| Substance Name | MIRABEGRON |
| Active Ingredient Strength | 25 mg/1 |
| Pharm Classes | beta3-Adrenergic Agonist [EPC],Adrenergic beta3-Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2021-07-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0469-2601 | Myrbetriq | mirabegron |
| 0469-2602 | Myrbetriq | mirabegron |
| 0469-5020 | Myrbetriq | mirabegron |
| 55154-8712 | Myrbetriq | mirabegron |
| 55154-8713 | Myrbetriq | mirabegron |
| 70518-2435 | Myrbetriq | mirabegron |
| 70518-3158 | Myrbetriq | mirabegron |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MYRBETRIQ 85595770 4263728 Live/Registered |
Astellas Pharma Inc. 2012-04-12 |